The FTC complaint against Carrot Neurotechnology lists an array of related assertions on that theme, including one that the app improved vision an average of 31 percent and two lines on the standard Stellen eye chart, and another that it helps mitigate presbyopia, the gradual loss of the ability to focus on nearby objects.
The FTC also reprimanded Carrot for not disclosing Seitz’s connection to the company when it cited his own research. Seitz says as soon as the FTC brought that to the company's attention, it disclosed the potential conflict of interest on its site.
Standing by Claims
Despite the agreement with the FTC, Seitz stands by the original UltimEyes claims. He called the FTC action “dangerous.”
“Is it a good thing that you have the FTC not just going after companies, but going after individuals when they’re trying to take the university mission of taking research and translating it to the public good?" he said. "Scientists should be incentivized to translate the research in the way I’m doing.”
Seitz has laid out his concerns in an open letter on his UC Riverside faculty page, asking friends and colleagues to post supportive comments with the FTC during the public comment period. Seitz said “numerous scientists” have come to the defense of the company.
“The government really needs to be listening to scientists here," he said. "They ignored experts we brought to testify and the scientific literature. They're using us as a way to establish some precedent so they can go after some larger companies in the industry."
The FTC said UltimEyes racked up more than $350,000 in U.S. sales from January 2012 to June 2015. Seitz acknowledges that if the app had hit it big, he would have gained financially. But, he said, “my main aim was to let the public get a hold of my research.” He said neither he nor his partner made any money from the app.
In its complaint, the FTC also cited a video that was posted on the UltimEyes site featuring Seitz and others discussing a study involving the 2013 UC Riverside baseball team, which ostensibly improved its performance after going through the app's exercises. In the video, a researcher says players reported they could “see things in dimmer light conditions, being able to see the ball better, being able to hit the ball better.”
Seitz says UltimEyes is based on perceptual learning, which he describes as "an improvement in a perceptual task induced by practice or experience. " The National Institutes of Health gave him a $1.7 million grant in 2013 to study the field.
Last year, Mashable tested the app out on an iPad and called it “half-game, half-eye exam.”
[Scroll to the bottom of this post for a video of the app in action.]
The UC Riverside baseball experiment was also the subject of a paper published in Current Biology, co-authored by Seitz. (Not to mention the subject of a Southern California Public Radio story in 2014).
That was one of three peer-reviewed studies, Seitz says, that prove UltimEyes does what it said. He said the FTC went after the app because the agency wants to see randomized, double blind studies to substantiate such claims. Seitz does not agree with that standard.
“They’re saying that if research is not done with a double blind placebo study, it doesn’t provide evidence of anything. ... But if you talk with most scientists, they say that there are tons of studies that use that methodology that are junk, and tons of studies that don’t use it that are informative.
“It’s a useful study design that provides information and context. It has great purpose, but there are many circumstances -- and this research is actually one of them -- where it doesn’t apply.”
The FTC declined to comment.
Federal Agencies "Doing a Reasonable Job" of Policing Apps
Dr. John Halamka, co-chair of the federal Health Information Technology Standards Committee, which advises the U.S. Department of Health and Human Services on technology and health care, does not agree with Seitz that the FTC overreached in taking action against his app. He says requiring a stringent level of proof is appropriate here.
"This is not one that is just face valid, or peer review could say, ‘okay sounds reasonable.’ It needs to be proven," he said, adding that peer review doesn't prove "rigorous scientific evaluation of a phenomena."
Halamka said using UltimEyes presents a certain level of risk to the public because it involves diagnosis or therapy.
"In the case of apps that are making claims that may or may not be true, if this is a therapy claiming a result, I think all of our federal agencies are doing a reasonable job to ask for rigor."
More to Come?
Enforcement actions like the one against UltimEyes are probably going to happen more frequently, says Bradley Merrill Thompson, a lawyer at Epstein, Becker & Green who works on regulatory issues with medical device and drug companies.
“The agreement is the next step in a whole series of cases the FTC has brought with respect to mobile applications," he said. Last month, the FTC barred a company from making claims that the“Mole Detective” line of apps could detect melanoma.
"I fear that there will be a lot more cases, ” Merrill Thompson said. "If you look at the mobile apps being promoted, it’s still the wild west out there. There’s still a lot of very small organizations operating out of their garage, making boastful claims about their technology."
KQED Future of You editor Christina Farr wrote about the proliferation of unproven claims by health-related apps for Reuters in 2014. She reported that a recent study from the New England Center for Investigative Research revealed that of the 1,500 health apps it evaluated, 20 percent claimed to treat or cure medical problems, but only a small percentage of them had been clinically validated.
Farr wrote that the FDA lacks the resources to monitor all the health-related apps on the market.
Bradley Merrill Thompson says the FDA has been “suspiciously quiet” on the topic.
“One would have to be suspicious that the FDA and FTC are collaborating behind the scenes, and the FTC has agreed to be the bad cop,” said Merrill Thompson. “The FDA has been embattled over the past few years as being too heavy-handed and too burdensome in regard to mobile apps.”
He explained that in a case like the one against UltimEyes, the FTC is viewing the app as a medical device, which comes under the purview of both agencies.
“Clearly there’s overlap,” he said, and either agency could have brought an action.